MAUDE Adverse Event Report: AESCULAP AG HISTOACRYL FLEXIBLE; TISSUE ADHESIVES

Model Number 1051250P

Device Problem Clumping in Device or Device Ingredient (1095)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The glue flakes - crumbles - and the wound opens.Glue flakes and crumbles after use.

Manufacturer Narrative

Samples received: 1 unopened box.Analysis and results: there are no previous complaints of this code batch.4,000 units of this product were manufactured and distributed in the market, there are 10 units in stock.Received 5 unopened pouches.The purity in the n-butyl cyanoacrylate of the samples received were analyzed and the results fulfill the oem specifications.Adhesive force has also been tested and the result is 346.2 n, well above the requirement that is 20 n minimum.Reviewed the batch manufacturing record this product had a normal process and the results during the process fulfills the oem requirements.There is a deviation prior to the release of the product, it was related to the ampoules, they were approved.Remarks: as indicated in the histoacryl flexible instructions for use: "closure of minimum-tension skin wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations." "hold the edges together for approximately 30 seconds after application to allow histoacryl flexible to cure and to prevent displacement of the wound edges." final conclusion: complaint is not justified.Although the results of the samples received fulfills the oem requirements, note is taken of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: HISTOACRYL FLEXIBLE
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5676742
• MDR Text Key: 45856868
• Report Number: 2916714-2016-00407
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 1051250P
• Device Catalogue Number: 1051250P
• Device Lot Number: 215462N2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/18/2016
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other